FibromyalgiaPhase 2NCT01586637
Art Therapy to Treat Women With Fibromyalgia
A Phase 2 study testing Art Therapy and Walking in people with Fibromyalgia, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Effectiveness of an art therapy program for the treatment of pain and improvements in both quality of life and body image of patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Art Therapy and Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Classification of fibromyalgia by ACR criteria (Wolf et al, 1990)
- Females
- Without distinction of race
- Age 18 to 65 years
- Do not have changed treatment for fibromyalgia for at least 3meses
- signing the consent form
Who cannot join
- Other ostearticulares rheumatic and painful
- Decompensated cardio-respiratory diseases
- Perform physical activity more than 2x a week for more than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Art Therapy Program for Women With Fibromyalgia: Randomized, Controlled, Blinded Study
Effectiveness of an art therapy program for the treatment of pain and improvements in both quality of life and body image of patients with fibromyalgia.
Read the detailed description
Fibromyalgia (FM) is a chronic non-inflammatory syndrome characterized by diffuse pain throughout the body, sleep disorder, stiffness, fatigue, depression and other psychological problems. Patients with FM feel incapable of performing the majority of activities of daily living. Medication offers only short-term benefits. Thus, it is necessary to include other measures for treatment, such as physical activity and patient education. Art therapy combine the field of psychology with artistic activities, working with therapeutic and instructive aspects as well as the potential for personal growth contained in all forms of art.
- Conditions
- Fibromyalgia
- Being tested
- Art Therapy, Walking
- Keywords
- Fibromyalgia, Art Therapy, Pain, Quality of life, Body Image
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyOther
Also called Rehabilitation, exercise, physical therapy
This group performed dance classes and regarding the art therapy they have art classes where they learn how to use the drawing to express feelings. The classes were twice a week.
WalkingOther
Also called Rehabilitation, exercise, physical therapy
The group walked twice a week during one hour.
| Study group | Role | What they receive |
|---|---|---|
| Art Therapy | Experimental | This group performed dance classes and regarding the art therapy they have art classes where they learn how to use the drawing to express feelings. The classes were twice a week. Receives: Other: Art Therapy |
| Walking | Experimental | The group walked twice a week during one hour. Receives: Other: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Evaluated with the visual analogue scale
Measured: baseline, after 10 weeks, 20 weeks and 40 weeks
Secondary outcomes (4)
Change in fibromyalgia impact
Evaluated using the Fibromyalgia Impact Questionnaire
Measured: Baseline, after 10, 20 and 40 weeks
Change in Quality of life
Evaluated using the SF-36 questionnaire
Measured: Baseline, after 10, 20 and 40 weeks
Change in Body image
Evaluated using the Body Dismorphic Disorder Examination (BDDE) questionnaire
Measured: Basline, after 10, 20 and 40 weeks
Change in Functional capacity
Evaluated using the six minute walk test
Measured: Baseline, after 10, 20 and 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andréia S Baptista, PT, Federal University of São Paulo
- Investigators
- Andréia S Baptista, PT, MSc, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586637
- Sponsor's protocol ID
- 0206/10
- Status last verified
- Apr 2012
- First submitted
- 16 Feb 2012
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Art Therapy Program for Women With Fibromyalgia: Randomized, Controlled, Blinded Study
- ClinicalTrials.gov ID
- NCT01586637
- Acronym / sponsor ID
- 0206/10
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Art Therapy, Pain, Quality of life, Body Image
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effectiveness of an art therapy program for the treatment of pain and improvements in both quality of life and body image of patients with fibromyalgia.
Detailed description
Fibromyalgia (FM) is a chronic non-inflammatory syndrome characterized by diffuse pain throughout the body, sleep disorder, stiffness, fatigue, depression and other psychological problems. Patients with FM feel incapable of performing the majority of activities of daily living. Medication offers only short-term benefits. Thus, it is necessary to include other measures for treatment, such as physical activity and patient education. Art therapy combine the field of psychology with artistic activities, working with therapeutic and instructive aspects as well as the potential for personal growth contained in all forms of art.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art Therapy | Experimental | Other: Art TherapyThis group performed dance classes and regarding the art therapy they have art classes where they learn how to use the drawing to express feelings. The classes were twice a week. |
| Walking | Experimental | Other: WalkingThe group walked twice a week during one hour. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Classification of fibromyalgia by ACR criteria (Wolf et al, 1990)
- Females
- Without distinction of race
- Age 18 to 65 years
- Do not have changed treatment for fibromyalgia for at least 3meses
Key exclusion criteria (3 listed)
- Other ostearticulares rheumatic and painful
- Decompensated cardio-respiratory diseases
- Perform physical activity more than 2x a week for more than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art TherapyAlso: Rehabilitation, exercise, physical therapyThis group performed dance classes and regarding the art therapy they have art classes where they learn how to use the drawing to express feelings. The classes were twice a week. | Other | Art Therapy |
| WalkingAlso: Rehabilitation, exercise, physical therapyThe group walked twice a week during one hour. | Other | Walking |
Primary outcome
Change in Pain
Time frame: baseline, after 10 weeks, 20 weeks and 40 weeks
Evaluated with the visual analogue scale
4 secondary outcomes
Change in fibromyalgia impact
Time frame: Baseline, after 10, 20 and 40 weeks
Change in Quality of life
Time frame: Baseline, after 10, 20 and 40 weeks
Change in Body image
Time frame: Basline, after 10, 20 and 40 weeks
Change in Functional capacity
Time frame: Baseline, after 10, 20 and 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andréia S Baptista, PT, MSc principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Art Therapy and Walking in people with Fibromyalgia, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: baseline, after 10 weeks, 20 weeks and 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2012.